ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Serious Adverse Event (SAE)

A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect, or precaution. A serious adverse event includes any experience that:

1. It is life threatening

2. It is permanently disabling

3. Requires inpatient hospitalization

4. Prolongs hospitalization

5. (For drugs) results in congenital anomaly, cancer or overdose

Publication Source: Committees on Human Research

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